Fujirebio Diagnostics Recalls Lumipulse β-Amyloid Plasma Controls Over Inaccurate Alzheimer's Test Results
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Fujirebio Diagnostics, Inc. is recalling specific lots of Lumipulse β-Amyloid Plasma Controls due to a defect that may cause falsely elevated results and incorrect Alzheimer's disease classifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Fujirebio Diagnostics, Inc. has initiated a voluntary recall of its Lumipulse β-Amyloid Plasma Controls. The company identified an issue where customers may experience inaccurate test results, specifically observing a higher frequency of classifications in the indeterminate and positive zones. This is caused by falsely elevated positive or indeterminate ratio results, which can lead to an incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease or requiring additional, potentially unnecessary clinical testing.
Which Products Are Affected
The recall affects the following medical device components:
- Product Name: Lumipulse β-Amyloid Plasma Controls (Two levels of liquid frozen controls)
- Model/Catalog Number: 81559
- UDI-DI: 05414470815593
- Lot Number: T8B6116U
- Quantity: 179 units
The affected products were distributed to laboratories in the following states: Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Washington.
What You Should Do
Fujirebio Diagnostics, Inc. notified affected customers via an initial firm notification letter sent on December 11, 2025. Laboratories and healthcare providers using these controls should review their inventory for the affected lot number (T8B6116U) and follow the specific instructions provided in the manufacturer's notification letter regarding the handling and use of the product.
Why This Matters
This recall is significant because inaccurate diagnostic results can lead to the misdiagnosis of Alzheimer's disease, potentially causing patients to undergo further unnecessary medical testing or receive incorrect clinical assessments.
Source
Information provided by the FDA under recall number Z-1307-2026.
Original source: FDA Official Notice ↗
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